Catheter assembly

ABSTRACT

Embodiments of a catheter assembly are disclosed. The catheter assembly comprises a shaft; at least one connector assembly. The connector assembly can comprise a first connector portion and a second connector portion, wherein the first connector portion is fixedly coupled to a distal end of the shaft, and is coupled to the second connector portion with a limited degree of freedom of movement by at least one radially extending pin retained within at least one slot on the second connector portion. The at least one slot can have an oversized circumferential dimension that allows limited rotation of the second connector portion relative to the first connector portion about a longitudinal axis of the shaft.

RELATED APPLICATIONS

This application is a continuation of International Application No.PCT/US2018/053532, filed Sep. 28, 2018, which claims the benefit of U.S.Provisional Patent Application No. 62/573,883, filed on Oct. 18, 2017.The foregoing applications are incorporated by reference in theirentirety herein for all purposes.

FIELD

The present disclosure concerns embodiments of a catheter assembly, suchas a delivery apparatus for implanting a prosthetic heart valve.

BACKGROUND

Endovascular delivery devices, such as catheters, can be used in variousprocedures to deliver prosthetic medical devices or instruments tolocations inside the body that are not readily accessible by surgery orwhere access without surgery is desirable. Access to a target locationinside the body can be achieved by inserting and guiding the deliverydevice through a pathway or lumen in the body, including, but notlimited to, a blood vessel, an esophagus, a trachea, any portion of thegastrointestinal tract, a lymphatic vessel, to name a few. For example,a prosthetic heart valve can be mounted in a crimped state on the distalend of a delivery device and advanced through the patient's vasculature(e.g., through a femoral artery and the aorta) until the prostheticvalve reaches the implantation site in the heart. The prosthetic valvecan then be expanded to its functional size such as by inflating aballoon on which the prosthetic valve is mounted, or by deploying theprosthetic valve from a sheath of the delivery device so that theprosthetic valve can self-expand to its functional size.

The usefulness of delivery devices is largely limited by the ability ofthe device to successfully navigate through small vessels and aroundbends in the vasculature, such as around the aortic arch. Since the paththrough the patient's vasculature to the intended site is often long andtortuous, steering forces must be transmitted over great distances. Itis preferably for a delivery catheter to have sufficient axial strengthso that the physician can push through the patient's vasculature via aforce applied at the proximal end of the catheter. In addition, thedistal part of the delivery catheter preferably includes a steerablesection having sufficient flexibility so that it can pass throughtortuous anatomy without sacrificing rigidness of the catheter shaft.However, delivery catheters can be too stiff and be difficult to pushthrough the vasculature. Hence, there is a need for delivery catheterswith enhanced flexibility.

SUMMARY

This summary is meant to provide some examples and is not intended to belimiting of the scope of the invention in any way. For example, anyfeature included in an example of this summary is not required by theclaims, unless the claims explicitly recite the features. Also, thefeatures, components, steps, concepts, etc. described in examples inthis summary and elsewhere in this disclosure can be combined in avariety of ways. Various features and steps as described elsewhere inthis disclosure may be included in the examples summarized here.

Disclosed herein are steerable catheter devices and related methods,which can be used to deliver a medical device, tools, agents, or othertherapy to a location within a body of a subject. In someimplementations, the steerable catheter devices can be used to deliver amedical device through the vasculature, such as to a heart of thesubject.

Certain embodiments of the disclosure concern a catheter assembly thatincludes a shaft and a connector assembly. The connector assembly caninclude a first connector portion and a second connector portion. Thefirst connector portion can be fixedly coupled to a distal end of theshaft, and is rotatably coupled to the second connector portion by atleast one radially extending pin retained within at least one slot onthe second connector portion. The at least one slot can have anoversized circumferential dimension that allows limited rotation of thesecond connector portion relative to the first connector portion about alongitudinal axis of the shaft.

In some embodiments, the at least one slot can be sized to allow limitedtilting of the second connector portion with respect to the longitudinalaxis of the shaft.

In some embodiments, the at least one slot can have an oversized widthin a direction along the longitudinal axis that allows limited axialmovement of the first connector portion relative to the second connectorportion.

In some embodiments, the at least one slot can include first and secondslots and the at least one pin comprises first and second pins disposedin the first and second slots, respectively.

In some embodiments, each slot can have an arc length around thelongitudinal axis of less than 180 degrees.

In the foregoing embodiments, the first connector portion can include adistal end portion that extends into an axial bore of the secondconnector portion, and the at least one pin can extend radiallyoutwardly from the distal end portion into the at least one slot in thesecond connector portion.

In the foregoing embodiments, the second connector portion can includeone or more attachment features configured to form a releasableattachment with corresponding retaining arms of an implantable medicaldevice.

In certain embodiments, the one or more attachment features can includeone or more recesses configured to receive the one or more retainingarms of the implantable medical device.

In certain embodiments, the catheter assembly can further include anouter sheath configured to extend over the connector assembly and theimplantable medical device so as to retain the implantable medicaldevice in a radially compressed state within the sheath when theretaining arms are in engagement with the attachment features of thesecond connector portion.

In the foregoing embodiments, the catheter assembly can further includeanother shaft having a proximal end connected to the second connectorportion.

Certain embodiments of the disclosure also concern a delivery apparatusfor delivering an implantable device via a patient's vasculature. Thedelivery apparatus includes an outer sheath, a shaft extending throughthe outer sheath; and a connector assembly. The connector assembly caninclude a first connector portion and a second connector portion. Thefirst connector portion can be fixedly coupled to a distal end of theshaft. The second connector portion can be coupled to the firstconnector portion such that the second connector portion can rotaterelative to the first connector portion about a longitudinal axis of theshaft and can tilt with respect to the longitudinal axis of the shaft.The second connector portion can include one or more attachment featuresconfigured to form a releasable attachment with corresponding retainingarms of a radially expandable implantable medical device. The outersheath can be configured to extend over the connector assembly and theimplantable medical device so as to retain the implantable medicaldevice in a radially compressed state within the sheath when theretaining arms of the implantable medical device are placed inengagement with the attachment features of the second connector portion.

In some embodiments, the second connector portion can be coupled to thefirst connector portion such that the second connector portion can moveaxially relative to the first connector portion a limited amount in adirection parallel to the longitudinal axis.

In some embodiments, the second connector portion can be coupled to thefirst connector portion by at least one radially extending pin retainedwithin at least one slot on the second connector portion.

In some embodiments, the second connector portion can be coupled to thefirst connector portion by at least one radially extending pin retainedwithin at least one slot on the first connector portion.

In some embodiments, the at least one slot can have an oversizedcircumferential dimension that allows limited rotation of the secondconnector portion relative to the first connector portion about thelongitudinal axis of the shaft.

In some embodiments, the at least one slot can be sized to allow limitedtilting of the second connector portion with respect to the longitudinalaxis of the shaft.

In some embodiments, the at least one slot can have an oversized widthin a direction along the longitudinal axis that allows limited axialmovement of the first connector portion relative to the second connectorportion.

In some embodiments, the at least one slot can include first and secondslots and the at least one pin can include first and second pinsdisposed in the first and second slots, respectively, and the first slotbeing opposite the second slot with respect to the longitudinal axis.

In some embodiments, the attachment features of the second connectorportion can include one or more recesses configured for receiving one ormore retaining arms of the implantable device.

Further, certain embodiments of the disclosure also concern an assemblyincluding an outer sheath, a first shaft extending through the outersheath, a second shaft extending through the first shaft, a nose conemounted on a distal end portion of the second shaft, a connectorassembly, and a radially expandable and compressible prosthetic heartvalve. The connector assembly can include a proximal connector portionand a distal connector portion. The proximal connector portion can befixedly coupled to a distal end of first shaft. The distal connectorportion can be rotatably coupled to the proximal connector portion by atleast a pin retained within a slot in the distal connector portion. Theslot can have an oversized circumferential dimension that allows limitedrotation of the distal connector portion relative to the proximalconnector portion about a longitudinal axis of the first shaft, limitedtilting of the distal connector portion with respect to the longitudinalaxis, and limited axial movement of the distal connector portionrelative to the proximal connector portion in a direction parallel tothe longitudinal axis. The distal connector portion can include one ormore attachment features. The prosthetic heart valve can be retained ina radially compressed state within the sheath and having one or moreretaining arms that engage respective attachment features of the distalconnector portion.

The foregoing and other objects, features, and advantages of theinvention will become more apparent from the following detaileddescription, which proceeds with reference to the accompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosed devices/apparatuses, systems, methods, etc. may be betterunderstood with reference to the following drawings.

FIG. 1 shows a side elevation view of an exemplary catheter assemblyincluding a delivery apparatus and a prosthetic heart valve that is in aradially compressed state.

FIG. 2 shows a top perspective view of a distal portion of the exemplarydelivery apparatus depicted in FIG. 1.

FIG. 3 shows an expanded prosthetic heart valve along a distal portionof the exemplary catheter assembly of FIG. 1.

FIG. 4 shows a top perspective view of an exemplary connector assemblyincluded in the exemplary delivery apparatus depicted in FIG. 2.

FIG. 5 shows a cross-sectional view of the connector assembly of FIG. 4taken along line 5-5 of FIG. 4.

FIG. 6 shows another cross-sectional view of the connector assembly ofFIG. 4 taken along line 6-6 of FIG. 4.

FIG. 7A shows an enlarged view of an exemplary connector assembly andits coupling with a shaft of the delivery apparatus.

FIG. 7B shows an exemplary embodiment of the connector assembly and itscoupling with a shaft of the delivery apparatus.

FIG. 7C shows an exemplary embodiment of the connector assembly and itscoupling with a shaft of the delivery apparatus.

FIG. 8 shows a side elevation view of the exemplary connector assemblydepicted in FIG. 4 and illustrates its tilting movement.

FIG. 9 shows a cross-sectional view of the exemplary connector assemblydepicted in FIG. 4 and illustrates its rotational movement.

While the present disclosure is subject to various modifications andalternative forms, specific embodiments thereof have been shown by wayof example in the drawings and will herein be described in detail. Theinvention should be understood to not be limited to the particular formsdisclosed, but to cover all modifications, equivalents, and alternativesfalling within the spirit and scope of the present disclosure.

DETAILED DESCRIPTION

The following description and accompanying figures, which describe andshow certain embodiments, are made to demonstrate, in a non-limitingmanner, several possible configurations of systems, platforms, devices,methods, etc. that may be used for various aspects and features of thepresent disclosure.

In some embodiments, a delivery apparatus that can be used to deliver amedical device, tools, agents, or other therapy to a location within thebody of a subject can include one or more steerable catheters and/orsheaths. Examples of procedures in which steerable catheters and sheathsare useful include cardiovascular, neurological, urological,gynecological, fertility (e.g., in vitro fertilization, artificialinsemination), laparoscopic, arthroscopic, transesophageal,transvaginal, transvesical, transrectal, and procedures including accessin any body duct or cavity. Particular examples include placingimplants, including stents, grafts, embolic coils, and the like;positioning imaging devices and/or components thereof, includingultrasound transducers; and positioning energy sources, for example, forperforming lithotripsy, RF sources, ultrasound emitters, electromagneticsources, laser sources, thermal sources, and the like.

In some embodiments, the delivery apparatus can include a steerableshaft such as a guide sheath having one or more delivery catheterscoaxially disposed within the guide sheath. The delivery apparatus cancomprise one or more eccentrically positioned pull wires configured tocause the steerable shaft to curve in a given direction, or tostraighten. In some embodiments, the delivery apparatus can be used todeliver a medical device through the vasculature, such as to a heart ofthe subject. In certain configurations, a balloon-inflatable orself-expandable prosthetic heart valve can be mounted on a distalportion of the delivery apparatus. Exemplary configurations of theprosthetic heart valve and implant catheter are further disclosed inU.S. Patent Application Publication Nos. 2013/0030519, 2012/0123529,2010/0036484, 2010/0049313, 2010/0239142, 2009/0281619, 2008/0065011,and 2007/0005131, each of which is incorporated by reference herein. Inaddition, it should be understood that the delivery apparatus can beused to deliver any of various other implantable devices, such asdocking devices, leaflet clips, annuloplasty devices, etc.

As an exemplary embodiment, FIG. 1 shows a catheter assembly 10 thatincludes a prosthetic heart valve 80 mounted on a delivery apparatus 12.FIG. 2 shows a distal portion of the delivery apparatus 12, according toone exemplary embodiment.

As shown, the delivery apparatus 12 can include a first shaft 14, aconnector assembly 20 that is coupled to a distal end portion of thefirst shaft 14, an outer sheath 16 sized to extend over the first shaft14 and the connector assembly 20, a second shaft 18 (which can also bereferred to as an “inner shaft” in the illustrated embodiment) extendingthrough the first shaft 14 and the connector assembly 20, and a nosecone 22 connected to a distal end 18d of the inner shaft 18. A guidewire 76 can extend through the central lumen of the inner shaft 18 andthe inner lumen of the nose cone 22, so that the delivery apparatus 12can be advanced over the guide wire 76 inside the patient's vasculature.

The connector assembly 20 in the illustrated embodiment includes a firstconnector portion 26 and a second connector portion 28, wherein thefirst connector portion 26 is positioned proximally relative to thesecond connector portion 28. The first connector portion 26 (which canbe referred to as a “proximal connector portion” in the illustratedembodiment) can be fixedly coupled to the distal end 14d of the firstshaft 14, and the first connector portion 26 can be generally coaxialwith the first shaft 14. The second connector portion 28 (which can bereferred to as a “distal connector portion” in the illustratedembodiment) can be coupled to the first connector portion 26 so as topermit limited movement of the second connector portion relative to thefirst connector portion.

As indicated in FIG. 2 and described more fully below, the secondconnector portion 28 can be configured to have one or multiple degreesof freedom to move relative to the first connector portion 26. Forexample, with respect to the first connector portion 26, the secondconnector portion 28 can translate axially (in the directions indicatedby double-headed arrow A) along the longitudinal axis 24 of the firstshaft 14, rotate in a plane that is transverse to the longitudinal axis24 (in the directions indicated by double-headed arrow R), and/oraxially tilt with respect to the longitudinal axis 24 (in the directionsindicated by arrow T). Various combinations of degrees of these and/orother freedom of movement are possible.

The delivery apparatus 12 can have a device retaining portion 78 locatedbetween the connector assembly 20 and the nose cone 22. The deviceretaining portion 78 can be configured to accommodate an implantablemedical device, such as a prosthetic heart valve 80 (see e.g., FIG. 1),in a radially compressed state within the outer sheath 16. As describedherein, the prosthetic heart valve 80 can be balloon inflatable,self-expandable, mechanically-expandable, and/or one or morecombinations of these.

As described more fully below, the outer sheath 16 can be configured tomove axially (or longitudinally) relative to the first shaft 14 and thesecond shaft 18 between a first, distal position extending over thedevice retaining portion 78 and the implantable medical device fordelivery through the vasculature of a patient (as shown in FIG. 1) and asecond, proximal position in which the distal end of the outer sheath isproximal to the device retaining portion 78 (as shown in FIG. 2) toallow the implantable medical device to be expanded at the desiredimplantation site, as further described below.

For example, as shown in FIGS. 1 and 3 and described more fully below,the prosthetic heart valve 80 can have one or more retaining arms 84that engage respective attachment features of the connector assembly 20.When the prosthetic heart valve 80 is deployed from the sheath (e.g., bysliding the outer sheath 16 proximally or sliding the inner shaft 18distally), the retaining arms 84 can disengage from respectiveattachment features. Accordingly, the prosthetic heart valve 80 can bereleased from the device retaining portion 78, and expanded to itsfunctional size (see e.g., FIG. 3) for deployment at the target site.

In some embodiments, the prosthetic heart valve 80 can beself-expandable such that the prosthetic heart valve 80 automaticallyexpands from the radially compressed state to a radially expanded stateonce it is deployed from the outer sheath 16. In other embodiments, theprosthetic heart valve 80 can be configured to be expanded by anexpansion device (e.g., an inflatable balloon) or combination ofexpansion devices.

As shown in FIG. 1, the delivery apparatus 12 can include a handle 68 ata proximal end thereof. During delivery of the implantable medicaldevice (e.g., the prosthetic heart valve 80), the handle 68 can bemaneuvered by a surgeon to advance and retract the delivery apparatus 12through the patient's vasculature.

In one exemplary, non-limiting embodiment illustrated in FIG. 1, thehandle 68 can include a knob or a plurality of knobs (e.g., 1, 2, 3, 4,or more knobs) for controlling different components or aspects of thedelivery apparatus 12. For example, in one embodiment, the proximal end16 p of the outer sheath 16 can be operatively coupled to a first knob70, the proximal end 14 p of the first shaft 14 can be operativelycoupled to a second knob 72, and the proximal end 18 p of the innershaft 18 can be operatively coupled to a knob 74. The handle 68 canadditionally or alternatively include a button or a plurality of buttons(e.g., 1, 2, 3, 4, or more buttons) for controlling different componentsor aspects of the delivery apparatus 12.

In some embodiments, operation (e.g., rotational or axial movement) of aknob or button (e.g., the first knob 70) can cause the outer sheath 16to slide over and retain the implantable medical device (e.g., theprosthetic heart valve 80) or withdraw proximally so as to expose andrelease the implantable medical device. In some embodiments, operationof the first knob 70 can cause rotational twisting of the outer sheath16 relative to the first shaft 14 and the inner shaft 18.

In some embodiments, operation (e.g., rotational or axial movement) of aknob or button (e.g., the second knob 72) can cause the first shaft 14to rotate about and/or slide along its longitudinal axis 24. Because thedistal end 14d of the first shaft 14 is fixedly coupled to the firstconnector portion 26, operation of the second knob 72 can producelimited movement (e.g., rotational and/or axial movement) of the firstconnector portion 26 relative to the second connector portion 28.

In some embodiments, operation (e.g., rotational or axial movement) of aknob or button (e.g., the third knob 74) can cause the inner shaft 18(and the nose cone) to slide longitudinally relative to the first shaft14 and the outer sheath 16. For example, in certain embodiments, theinner shaft 18 can be moved distally to move the nose cone 22 distallyrelative to the sheath 16 so that the implantable medical device canthen be deployed from the sheath.

Further details of the construction of the handle with knobs and themeans for operating the handle and knobs are described in U.S. PatentApplication Publication Nos. 2013/0030519, 2009/0281619, 2008/0065011,and 2007/0005131, each of which is incorporated by reference herein.Optionally, different components of the delivery apparatus 12 can becontrolled by other actuation mechanisms (e.g., other knobs, buttons,joysticks, voice-controlled actuators, touch pads, touch screens, etc.)

FIG. 4 shows an exemplary connector assembly 20 in isolation withoutdisplaying other parts of the delivery apparatus 12. As shown, theconnector assembly 20 can include the first connector portion 26 and thesecond connector portion 28 that is distal to the first connectorportion 26. The first and second connector portions 26, 28 can begenerally cylindrical in shape, or can be one or more other shapes. Thefirst and second connector portions 26, 28 can be rotatably coupled toeach other by at least one radially extending pin 30 retained within atleast one slot 40 formed in the second connector portion 28.

FIGS. 5-6 show one exemplary, non-limiting embodiment of the detailedstructure of the connector assembly 20. As shown, the first connectorportion 26 can include a proximal end portion 42 and a distal endportion 44 connected by an intermediate portion 46. The proximal endportion 42 can be fixedly coupled to the distal end portion 14d of theshaft 14. While various shapes are possible, in one embodiment, eachportion 42, 44, 46 has a cylindrical or generally cylindrical shape butcan vary in cross-sectional area (e.g., the cross-section of theintermediate portion can have a smaller area, diameter, and/or thicknessthan the proximal and distal end portions). In some embodiments, eachportion 42, 44, 46 can have a non-cylindrical shape (e.g., thecross-sectional shape of the portion can be square, oval, hexagonal,etc.). The first connector portion 26 can comprise a sidewall 48defining a proximal lumen 50 along the proximal end portion 42 and adistal lumen 52 extending through the intermediate and distal endportions 44, 46. The proximal lumen 50 can have a larger interiordimension (e.g., diameter) than the distal lumen 52. To affix the shaft14 to the first connector portion 26, the distal end portion 14d of theshaft 14 can extend into the proximal lumen 50 and can be secured inplace, such as with an interference fit and/or a suitable adhesive.

The second connector portion 28 can include a distal end portion 54 anda proximal end portion 56. Each portion 54, 56 can have a generallycylindrical shape. In some embodiments, each portion 54, 56 can have anon-cylindrical shape (e.g., the cross-sectional shape of the portioncan be square, oval, hexagonal, etc.). The outer surface of the distalend portion 54 can define a plurality of recesses 32 and optional bosses34 extended therefrom, which form attachment features for forming areleasable connection with each of the retaining arms 84 of theprosthetic valve, as further described below. The second connectorportion 28 can comprise a sidewall 58 defining a proximal lumen 62 alongthe proximal end portion 56 and a distal lumen 60 along the distal endportion 54, wherein the proximal lumen 62 can have a larger interiordimension (e.g., diameter) than the distal lumen 60.

In the exemplary embodiment depicted in FIGS. 5-6, the outer dimensionof the distal end portion 44 of the first connector portion 26 issmaller than the interior dimension of the proximal lumen 62 of thesecond connector portion 28 such that there is a radial gap between theouter surface of the distal end portion 44 and the inner surface of theproximal lumen 62. Accordingly, the distal end portion 44 of the firstconnector portion 26 can be inserted into the proximal lumen 62 (whichcan also be referred to as an “axial bore”) of the second connectorportion 28. The respective lumens 50, 52, 62, and 60 of the first andsecond connector portions 26, 28 can collectively define a centralpassage for the inner shaft 18 to extend through.

In the exemplary embodiment depicted in FIG. 6, two pins 30′, 30″ extendradially outward from the distal end portion 44 of the first connectorportion 26 respectively into two slots 40′, 40″ formed in the proximalend portion 56 of the second connector portion 28.

In some embodiments, the pins 30′, 30″ can be embedded in and extendradially outward from respective recesses 64′, 64″ located at the distalend portion 44 of the first connector portion 26. The recesses 64′, 64″,which can be formed in the sidewall 48 at diametrically opposedlocations. The radial inner end portions of the pins 30, 30″ can besecured in the recesses 64′, 64″, such as with an adhesive and/or africtional fit. Alternatively, the sidewall 48 can be without recesses64′, 64″ and the pins 30′, 30″ can be secured to the outer surface ofthe sidewall 48. Optionally, the pins 30′, 30″ can be formed as integralparts of the first connector portion 26 (i.e., they form a unitarypiece) such that they protrude outwardly from the outer surface of thewall 48 without any recesses 64′, 64″. In the depicted embodiment, bothslots 40′, 40″ extend through the sidewall 58 of the second connectorportion 28, and they are arranged on opposite sides of the sidewall 58with respect to the longitudinal axis 24. Each of the slots 40′, 40″ canhave an arc length of less than 180 degrees.

Although the exemplary embodiment described herein have two pins 30 intwo slots 40, it should be understood that any number of pins 30 andslots 40 (e.g., 1, 2, 3, 4, or more, etc.) can be used. Further, theslots 40 are not necessarily equally spaced circumferentially.

In the embodiments shown in FIGS. 4-6, the pins 30′, 30″ have agenerally cylinder shape with a cross-sectional diameter D1. In someembodiments, the pins 30′, 30″ can have one or more othercross-sectional shapes (e.g., square, oval, hexagonal, etc.) with amaximum cross-sectional dimension D1. Each of the slots 40′, 40″, whichdefines an opening in the sidewall 58 of the second connector portion28, has a circumferential dimension (or length) L measuredcircumferentially and an axial dimension (or width) W measuredlongitudinally over the outer surface of the second connector portion28.

In some embodiments, the slot 40 can have an oversized circumferentialdimension L (i.e., L >D1) or arc length (measured in degrees) thatallows limited rotation (e.g., clockwise or counter-clockwise) of thesecond connector portion 28 relative to the first connector portion 26about the longitudinal axis 24 of the shaft 14 (see e.g., FIGS. 2 and9). The degree of rotational movement of the second connector portion 28relative to the first connector portion 26 can be limited by the length(L) of the slot 40.

In addition, the slot 40 can have an oversized width W (i.e., W >D1) ina direction along the longitudinal axis 24 that allows limited axialmovement (e.g., distally or proximally) of the second connector portion28 relative to the first connector portion 26. The degree of axialmovement of the second connector portion 28 relative to the firstconnector portion 26 can be limited by the width (W) of the slot 40.

The second connector portion 28 can also be configured to tilt relativeto the first connector portion 26 about a tilt axis 82 (FIG. 4) definedby the pins 30, 30″ by virtue of the arrangement of the distal endportion 44 of the first connector portion 26 with respect to the axialbore 62. For example, as noted above, the axial bore 62 of the secondconnector portion 28 can be oversized (e.g., in cross-sectionaldimension) relative to the distal end portion 44 of the first connectorportion 26 (e.g., D3 >D2 as illustrated in FIG. 6) such that there is anannular or radial gap between the adjacent surfaces of the first andsecond connector portions. This allows the second connector portion 28to tilt about the tilt axis 82 (in the directions indicated bydouble-headed arrow T in FIG. 2) wherein the tilt axis 82 extendsthrough the pins 30′, 30″ perpendicular to the longitudinal axis 24. Inthis manner, the pins 30′, 30″ function as a fulcrum, allowing thesecond connector portion 28 to tilt relative to the first connectorportion 26 about the tilt axis 82.

In addition, since the width W of the slots 40′, 40″ is greater than thedimension D1 of the pins 30′, 30″, the tilting motion of the secondconnector portion 28 relative to the first connector portion 26 is notnecessarily limited to tilting motion about tilt axis 82 extendingthrough the pins 30′, 30″. Explaining further, due to the width W beingoversized relative to the dimension D1 and the diameter D3 beingoversized relative to the diameter D2, the second connector portion 28can “float” relative to the first connector portion 26 inthree-dimensional space with movement of the second connector portion 28being constrained by contact between the pins 30, 30″ with the sides ofthe slots 40′, 40″. As such, the second connector portion 28 can shiftand/or tilt relative to the first connector portion such that thecentral axis 88 of the second connector portion 28 (FIG. 8) deviatesfrom the longitudinal axis 24 (i.e., movement of the second connectorportion 28 causes the central axis 88 to become non-collinear with thelongitudinal axis 24). Accordingly, in some embodiments, the secondconnector portion 28 can tilt and/or shift in any direction relative tothe first connector portion 26, with movement of the second connectorportion limited by the spacing or gap between the axial bore 62 and thedistal end portion 44 of the first connector portion 26 and the spacingor gap between the pins30, 30″ and the sides of the slots 40′, 40″.

In some embodiments, as noted above, the second connector portion 28 caninclude one or more attachment features configured to form a releasableattachment with corresponding retaining arms of an implantable medicaldevice, such as a prosthetic heart valve 80, retained in the deviceretaining portion 78 (see, e.g., FIGS. 1 and 3).

One exemplary, non-limiting embodiment of attachment features are shownin FIGS. 1-6. As depicted, the second connector portion 28 can have aplurality of circumferentially spaced recesses 32 formed in the outersurface of the distal end portion 54 and sized to receive respectiveretaining arms 84 of the prosthetic heart valve 80. Optionalradially-extending bosses or pins 34 can be disposed within theplurality of recesses 32. Each boss 34 can be so complimentarily shapedand sized to engage with a corresponding aperture 86 in a retaining arm84 of the prosthetic heart valve 80. Thus, by extending through thecorresponding apertures 86, the bosses can serve as anchors to helpsecure the retaining arms 84 within the recesses. The distal end of thesecond connector portion can be formed with a flange 36 that has aslightly larger outer diameter than the section in which the recesses 32are formed. The flange 36 can have one or more notches 38 along itscircumferential edge. The notches 38 can be in communication with therecesses 32 such that the retaining arms 84 can extend through thenotches.

When the prosthetic heart valve 80 is in a radially compressed state andattached to the delivery apparatus for delivery into a patient's body,the prosthetic heart valve 80 is positioned distal to the flange 36within the retaining portion 78. The retaining arms 84 extend throughthe notches 32 in the flange 36 so as to position the end portions ofthe retaining arms 84 within respective recesses 32. The sheath 16 isextended over the prosthetic heart valve 80 to retain the retaining arms84 within recesses 32 and to retain the prosthetic heart valve 80 in theradially compressed state.

Although FIG. 4 shows three recesses 32 (and three corresponding bosses34 and notches 38) that are equally spaced circumferentially around theouter surface of the second connector portion 28, it should beunderstood that any number of recesses 32 (and corresponding bosses 34and notches 38) can be included so long as they collectively engage withthe respective retaining arms 84 of the prosthetic heart valve 80.Further, it should be understood that the attachment features can takeany other forms so long as to enable releasable attachment with theimplantable medical device. For example, in some embodiments, theattachment features can include a suture retention member and a slidablerelease member, as disclosed in US 2014/0343670, which is incorporatedby reference herein.

After attaching the prosthetic heart valve 80 to the delivery apparatus12 as described above, the delivery apparatus can be inserted in thevasculature of a patient (e.g., a femoral artery and the aorta whendelivering a prosthetic aortic valve in a retrograde delivery approach).Because the implantable medical device can be releasably attached to thesecond connector portion 28, the connector assembly 20 in theillustrated embodiment supports limited, multiple degrees of movement ofthe implantable medical device retained within the outer sheath 16 atthe device retaining portion 78. As a result, the connector assembly 20can function as a flexible self-tracking joint, such that when pushingthe delivery apparatus 12 through a patient's vasculature, the distalportion of the delivery apparatus 12 (and the implantable medical deviceretained therein) can more easily track or follow the contour of thevasculature by passive deflections, for example, in one embodiment, inat least three independent degrees of freedom (by limited tilting,rotation, and/or translation) against resistance from the vascular wall.Such self-tracking capability is advantageous because it allows thephysician to more easily navigate the delivery apparatus 12 through achallenging vascular path, and in some embodiments reducing or eveneliminating the need to operate control mechanisms for steering thedelivery apparatus 12 (e.g., actively bending the distal portion throughpull wires to achieve a desired curvature).

FIG. 7A shows an enlarged view of the connector assembly 20 and itscoupling with the shaft 14 of the delivery apparatus 12 depicted in FIG.2.

FIG. 7B shows an exemplary connector assembly 100 incorporated in thedelivery apparatus 12 b, which can be used in place of and/or similarlyto connector assembly 20. The connector assembly 100 comprises the firstand second connector portions 102, 104, respectively (which can be thesimilar to portions 26, 28 and/or can include similar features,components, etc.). The first connector portion 102 is fixedly coupled tothe shaft 14, and the inner shaft 18 extends through the shaft 14 andthe connector assembly 100.

In the illustrated embodiment, the second connector portion 104 has aproximal end portion 106 which has an outer diameter that is smallerthan the interior diameter of a distal lumen 108 of the first connectorportion 102. Accordingly, the proximal end portion 106 of the secondconnector portion 104 can extend into the distal lumen 108 of the firstconnector portion 102.

In addition, the first and second connector portions 102, 104 can berotatably coupled to each other by one or more pins 30 extendingradially outwardly from the second connector portion 104 and retainedwithin respective slots 40 on the first connector portion 102.Similarly, a distal lumen 108 of the first connector portion 102 can beoversized relative to a proximal end portion 106 of the second connectorportion 28 b, and the slots 40 can be oversized in length and widthrelative to the cross-sectional dimensions of the pins 30 so that thesecond connector portion 104 can have a limited degree of freedom torotate around the longitudinal axis 24, and/or translate along thelongitudinal axis 24, and/or tilt in any direction relative to the firstconnector portion 102.

FIG. 7C shows an exemplary connector assembly 200 incorporated in adelivery apparatus 12c, which can be used in place of and/or similarlyto connector assembly 20 or 100. The connector assembly 200 comprises afirst connector portion 206 and a second connector portion 208 (whichcan be the similar to portions 26, 28 or portions 102, 106, and/or caninclude similar features, components, etc.). The first connector portioncan be fixedly coupled to a first shaft segment 202, and the secondconnector portion can be fixedly coupled to a second shaft segment 204.Similar to the connector assembly 20, the first and second connectorportions 206, 208 can be rotatably coupled to each other by one or morepins 30 extending from the first connector portion 206 and retainedwithin respective slots 40 on the second connector portion 208.

The connector assembly 200 can have the same configuration as theconnector assembly 20 previously described and include similar features,except that the second connector portion 208 is not formed with anyretaining features for retaining an implantable medical device. Instead,the connector assembly 200 is used as a linkage between adjacent ends oftwo shaft segments of a catheter assembly. Similar to the connectorassembly 20, a proximal lumen of the second connector portion 208 can beoversized relative to a distal end portion of the first connectorportion 206, and the slots 40 can be oversized in length and widthrelative to the cross-sectional dimensions of the pins 30 so that thesecond connector portion 208 can have limited rotational, axial, and/ortilting movement relative to the first connector portion 206. Becausethe second shaft segment 204 is fixedly coupled to the second connectorportion 208, any rotational, axial, and/or tilting movement of thesecond connector portion 208 can also cause corresponding rotational,axial, and/or tilting movement of the second shaft segment 204 relativeto the first shaft segment. In this manner, the connector assembly 200increases the flexibility of the shaft assembly along its length.

Although only two shaft segments are generally shown in the variousembodiment of the figures, it should be understood that a shaft assemblycan comprise any number of shaft segments coupled to end-to-end withrespective connector assemblies (e.g., 1, 2, 3, 4, 5, 6, or moreconnector assemblies 20, 100, 200 connected to multiple shaft segments)to enhance the flexibility of the shaft assembly along its length. Avariety of different types of connector assemblies (e.g., assemblies 20,100, 200) can be used in different locations along a shaft assembly aswell. Each shaft segment of the multi-segment hinged shaft assembly canhave a limited degree of rotational, axial, and/or tilting movementrelative to an attached connector assembly and an adjacent shaftsegment. In one implementation, connector assemblies can be used tointerconnect relatively short, non-flexible shaft segments, such asmetal shaft segments, to form a shaft assembly with a high degree offlexibility.

In FIGS. 7A-7C, the pins extend radially outwardly and are retained inrespective outer slots. For example, in FIG. 7A (and similarly in FIG.7C), because the distal end portion 44 of the first connector portion 26is inserted into the proximal lumen 62 of the second connector portion28, the slots 40 retaining the pins 30 are positioned exterior to thedistal end portion 44 from which the pins 30 extend radially outward. InFIG. 7B, because the proximal end portion 106 of the second connectorportion 104 is inserted into the distal lumen 108 of the first connectorportion 102, the slots 40 retaining the pins 30 are also positionedexterior to the proximal end portion 106 from which the pins 30 extendradially outward.

Although not shown, it should be understood that the pin-in-slotconfiguration can be structured differently such that the pins canextend inwardly and are retained in respective inner slots. For example,the connector assembly can have an inner portion inserted into thecentral lumen of an outer portion, and the pins can extend radiallyinward from the outer portion and be retained within corresponding innerslots located on the inner portion. The inner portion can be part of thefirst connector portion and the outer portion can be part of the secondconnector portion. Optionally, the inner portion can be part of thesecond connector portion and the outer portion can be part of the firstconnector portion. Similarly, the inner slots can be oversized relativeto the inwardly extending pins so that the second connector portion canhave limited rotational, axial, and/or tilting movement relative to thefirst connector portion.

General Considerations

The disclosed embodiments can be adapted to deliver and implantprosthetic devices in any of the native annuluses/valves of the heart(e.g., the pulmonary, mitral, and tricuspid annuluses/valves), and canbe used with any of various delivery approaches (e.g., retrograde,antegrade, transseptal, transventricular, transatrial, transvascular,etc.) or other organs.

For purposes of this description, certain aspects, advantages, and novelfeatures of the embodiments of this disclosure are described herein. Thedisclosed methods, apparatus, and systems should not be construed asbeing limiting in any way. Instead, the present disclosure is directedtoward all novel and nonobvious features and aspects of the variousdisclosed embodiments, alone and in various combinations andsub-combinations with one another. The methods, apparatus, and systemsare not limited to any specific aspect or feature or combinationthereof, nor do the disclosed embodiments require that any one or morespecific advantages be present or problems be solved. The technologiesfrom any example can be combined with the technologies described in anyone or more of the other examples. In view of the many possibleembodiments to which the principles of the disclosed technology may beapplied, it should be recognized that the illustrated embodiments areonly preferred examples and should not be taken as limiting the scope ofthe disclosed technology.

Although the operations of some of the disclosed embodiments aredescribed in a particular, sequential order for convenient presentation,it should be understood that this manner of description encompassesrearrangement, unless a particular ordering is required by specificlanguage set forth below. For example, operations described sequentiallymay in some cases be rearranged or performed concurrently. Moreover, forthe sake of simplicity, the attached figures may not show the variousways in which the disclosed methods can be used in conjunction withother methods. Additionally, the description sometimes uses terms like“provide” or “achieve” to describe the disclosed methods. These termsare high-level abstractions of the actual operations that are performed.The actual operations that correspond to these terms may vary dependingon the particular implementation and are readily discernible by one ofordinary skill in the art.

As used in this application and in the claims, the singular forms “a,”“an,” and “the” include the plural forms unless the context clearlydictates otherwise. Additionally, the term “includes” means “comprises.”Further, the terms “coupled” and “connected” generally meanelectrically, electromagnetically, and/or physically (e.g., mechanicallyor chemically) coupled or linked and does not exclude the presence ofintermediate elements between the coupled or associated items absentspecific contrary language.

Directions and other relative references (e.g., inner, outer, upward,downward, interior, exterior, etc.) may be used to facilitate discussionof the drawings and principles herein, but are not intended to belimiting. For example, certain terms may be used such as “inside,”“outside,”, “top,” “down,” and the like. Such terms are used, whereapplicable, to provide some clarity of description when dealing withrelative relationships, particularly with respect to the illustratedembodiments. Such terms are not, however, intended to imply absoluterelationships, positions, and/or orientations. For example, with respectto an object, an “upper” part can become a “lower” part simply byturning the object over. Nevertheless, it is still the same part and theobject remains the same. As used herein, “and/or” means “and” or “or”,as well as “and” and “or”.

In view of the many possible embodiments to which the principles of thedisclosed invention may be applied, it should be recognized that theillustrated embodiments are only preferred examples of the invention andshould not be taken as limiting the scope of the invention. Rather, thescope of the invention is defined by the following claims andencompasses all that falls within the scope of these claims.

1. A catheter assembly, comprising: a shaft; and a connector assemblycomprising a first connector portion and a second connector portion,wherein the first connector portion is fixedly coupled to a distal endof the shaft, and is rotatably coupled to the second connector portionby at least one radially extending pin retained within at least one sloton the second connector portion, wherein the at least one slot has anoversized circumferential dimension that allows limited rotation of thesecond connector portion relative to the first connector portion about alongitudinal axis of the shaft.
 2. The catheter assembly of claim 1,wherein the at least one slot is sized to allow limited tilting of thesecond connector portion with respect to the longitudinal axis of theshaft.
 3. The catheter assembly of claim 1, wherein the at least oneslot has an oversized width in a direction along the longitudinal axisthat allows limited axial movement of the first connector portionrelative to the second connector portion.
 4. The catheter assembly ofclaim 1, wherein the at least one slot comprises first and second slotsand the at least one pin comprises first and second pins disposed in thefirst and second slots, respectively.
 5. The catheter assembly of claim4, wherein each slot has an arc length around the longitudinal axis ofless than 180 degrees.
 6. The catheter assembly of claim 1, wherein thefirst connector portion comprises a distal end portion that extends intoan axial bore of the second connector portion, and the at least one pinextends radially outwardly from the distal end portion into the at leastone slot in the second connector portion.
 7. The catheter assembly ofclaim 1, wherein the second connector portion comprises one or moreattachment features configured to form a releasable attachment withcorresponding retaining arms of an implantable medical device.
 8. Thecatheter assembly of claim 7, wherein the one or more attachmentfeatures comprise one or more recesses configured to receive the one ormore retaining arms of the implantable medical device.
 9. The catheterassembly of any one of claim 7, further comprising an outer sheathconfigured to extend over the connector assembly and the implantablemedical device so as to retain the implantable medical device in aradially compressed state within the sheath when the retaining arms arein engagement with the attachment features of the second connectorportion.
 10. The catheter assembly of claim 1, further comprisinganother shaft having a proximal end connected to the second connectorportion.
 11. A delivery apparatus for delivering an implantable devicevia a patient's vasculature, comprising: an outer sheath; a shaftextending through the outer sheath; and a connector assembly comprisinga first connector portion and a second connector portion, the firstconnector portion being fixedly coupled to a distal end of the shaft,the second connector portion being coupled to the first connectorportion such that the second connector portion can rotate relative tothe first connector portion about a longitudinal axis of the shaft andcan tilt with respect to the longitudinal axis of the shaft; wherein thesecond connector portion comprises one or more attachment featuresconfigured to form a releasable attachment with corresponding retainingarms of a radially expandable implantable medical device; wherein theouter sheath is configured to extend over the connector assembly and theimplantable medical device so as to retain the implantable medicaldevice in a radially compressed state within the sheath when theretaining arms of the implantable medical device are placed inengagement with the attachment features of the second connector portion.12. The delivery apparatus of claim 11, wherein the second connectorportion is coupled to the first connector portion such that the secondconnector portion can move axially relative to the first connectorportion a limited amount in a direction parallel to the longitudinalaxis.
 13. The delivery apparatus of claim 11, wherein the secondconnector portion is coupled to the first connector portion by at leastone radially extending pin retained within at least one slot on thesecond connector portion.
 14. The delivery apparatus of claim 11,wherein the second connector portion is coupled to the first connectorportion by at least one radially extending pin retained within at leastone slot on the first connector portion.
 15. The delivery apparatus ofclaim 13, wherein the at least one slot has an oversized circumferentialdimension that allows limited rotation of the second connector portionrelative to the first connector portion about the longitudinal axis ofthe shaft.
 16. The delivery apparatus of claim 11, wherein the at leastone slot is sized to allow limited tilting of the second connectorportion with respect to the longitudinal axis of the shaft.
 17. Thedelivery apparatus of claim 11, wherein the at least one slot has anoversized width in a direction along the longitudinal axis that allowslimited axial movement of the first connector portion relative to thesecond connector portion.
 18. The delivery apparatus of claim 11,wherein the at least one slot comprises first and second slots and theat least one pin comprises first and second pins disposed in the firstand second slots, respectively, and the first slot being opposite thesecond slot with respect to the longitudinal axis.
 19. The deliveryapparatus of claim 11, wherein the attachment features of the secondconnector portion comprise one or more recesses configured for receivingone or more retaining arms of the implantable device.
 20. An assembly,comprising: an outer sheath; a first shaft extending through the outersheath; a second shaft extending through the first shaft; a nose conemounted on a distal end portion of the second shaft; a connectorassembly comprising a proximal connector portion and a distal connectorportion, the proximal connector portion being fixedly coupled to adistal end of first shaft, the distal connector portion being rotatablycoupled to the proximal connector portion by at least a pin retainedwithin a slot in the distal connector portion, wherein the slot has anoversized circumferential dimension that allows limited rotation of thedistal connector portion relative to the proximal connector portionabout a longitudinal axis of the first shaft, limited tilting of thedistal connector portion with respect to the longitudinal axis, andlimited axial movement of the distal connector portion relative to theproximal connector portion in a direction parallel to the longitudinalaxis, wherein the distal connector portion comprises one or moreattachment features; and a radially expandable and compressibleprosthetic heart valve retained in a radially compressed state withinthe sheath and having one or more retaining arms that engage respectiveattachment features of the distal connector portion.